Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||2 Years - 17 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Janssen Research & Development, LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Janssen Research & Development, LLC Clinical Trial|
|Principal Investigator Affiliation||Janssen Research & Development, LLC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Germany, Hungary, Israel, Japan, Poland, Russian Federation, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Open- Label Ustekinumab Intravenous (IV): Induction Period
All participants will receive a single IV administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).
Experimental: Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period
Participants will receive SC administration of ustekinumab q8w based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
Experimental: Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period
Participants will receive SC administration of ustekinumab q12w based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.
Drug: - Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
Drug: - Placebo
Matching placebo will be administered as SC injection.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.